ObesityPhase 2/3HEALTH[e]TEENNCT01560676
Reducing Obesity and Type 2 Diabetes in High Risk Youth
A Phase 2/3 study testing HEALTH[e]TEEN and HEALTH[e]TEEN + CST in people with Obesity and Type 2 Diabetes, run by Yale University at 1 site in United States.
Trial summary
Compare the effect of the HEALT[e]TEEN program and a HEALTH[e]TEEN plus coping skills training delivered to high school students on BMI, nutrition and physical activity behaviors, and self-efficacy over 6 months. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- HEALTH[e]TEEN and HEALTH[e]TEEN + CST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Aug 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Student enrolled in Health, Biology, or Public Health course
Who cannot join
- Cognitive ability unable to read or respond to questions in program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A School-based Internet Obesity Prevention Program for Adolescents
Compare the effect of the HEALT[e]TEEN program and a HEALTH[e]TEEN plus coping skills training delivered to high school students on BMI, nutrition and physical activity behaviors, and self-efficacy over 6 months.
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- HEALTH[e]TEEN, HEALTH[e]TEEN + CST
- Keywords
- Internet, School based, Obesity Prevention Program, Adolescents
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEALTH[e]TEENBehavioural
8 lessons over 6-8 weeks
HEALTH[e]TEEN + CSTBehavioural
12 lessons over 6-8 weeks
| Study group | Role | What they receive |
|---|---|---|
| HEALTH[e]TEEN | Active comparator | 8 lessons over 6-8 weeks Education on healthy eating and physical activity Behavioral support for self-monitoring and goal setting Receives: Behavioral: HEALTH[e]TEEN |
| HEALTH[e]TEEN + CST | Active comparator | 12 lessons over 6-8 weeks Education on healthy eating and coping skills training Behavioral support for self-monitoring and goal setting Receives: Behavioral: HEALTH[e]TEEN + CST |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Measured: 6 months
Secondary outcomes (3)
Dietary behavior
Healthy eating
Measured: 6 months
Sedentary behavior
Computer, TV, video games
Measured: 6 months
Physical activity
Moderate to vigorous exercise
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startSep 2009
- Primary completionJun 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Whittemore, Yale University
- Investigators
- Robin Whittemore, PhD, Principal investigator, Yale UniversityMargaret Grey, DrPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560676
- Sponsor's protocol ID
- 1008007228
- Acronym
- HEALTH[e]TEEN
- Status last verified
- Mar 2012
- First submitted
- 20 Mar 2012
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Whittemore R, Jeon S, Grey M. An internet obesity prevention program for adolescents. J Adolesc Health. 2013 Apr;52(4):439-47. doi: 10.1016/j.jadohealth.2012.07.014. Epub 2012 Sep 27.
PubMed 23299003
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A School-based Internet Obesity Prevention Program for Adolescents
- ClinicalTrials.gov ID
- NCT01560676
- Acronym / sponsor ID
- HEALTH[e]TEEN / 1008007228
- Conditions
- Obesity, Type 2 Diabetes
- Keywords
- Internet, School based, Obesity Prevention Program, Adolescents
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the effect of the HEALT[e]TEEN program and a HEALTH[e]TEEN plus coping skills training delivered to high school students on BMI, nutrition and physical activity behaviors, and self-efficacy over 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEALTH[e]TEEN | Active comparator | Behavioral: HEALTH[e]TEEN8 lessons over 6-8 weeks Education on healthy eating and physical activity Behavioral support for self-monitoring and goal setting |
| HEALTH[e]TEEN + CST | Active comparator | Behavioral: HEALTH[e]TEEN + CST12 lessons over 6-8 weeks Education on healthy eating and coping skills training Behavioral support for self-monitoring and goal setting |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Student enrolled in Health, Biology, or Public Health course
Key exclusion criteria (1 listed)
- Cognitive ability unable to read or respond to questions in program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEALTH[e]TEEN8 lessons over 6-8 weeks | Behavioural | HEALTH[e]TEEN |
| HEALTH[e]TEEN + CST12 lessons over 6-8 weeks | Behavioural | HEALTH[e]TEEN + CST |
Primary outcome
BMI
Time frame: 6 months
3 secondary outcomes
Dietary behavior
Time frame: 6 months
Sedentary behavior
Time frame: 6 months
Physical activity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
- Derived from this study: PubMed 23299003Whittemore R, Jeon S, Grey M. An internet obesity prevention program for adolescents. J Adolesc Health. 2013 Apr;52(4):439-47. doi: 10.1016/j.jadohealth.2012.07.014. Epub 2012 Sep 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Whittemore, PhD principal investigator
Yale University
Margaret Grey, DrPH principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HEALTH[e]TEEN and HEALTH[e]TEEN + CST in people with Obesity and Type 2 Diabetes, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01560676, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2012.